According to data from the Heart Failure Society of America (HFSA), heart failure (HF) is a common but often unrecognized and misdiagnosed condition that affects nearly 6 million Americans. HF is the only major cardiovascular disorder on the rise, with an estimated 400,000 to 700,000 new cases being diagnosed each year. The number of deaths in the United States from HF has more than doubled since 1979, averaging 250,000 per year, according to the HFSA. Less than 50% of HF patients are alive at 5 years after their initial diagnosis, and less than 25% are alive at 10 years. HF is the leading cause of hospitalization among Medicare beneficiaries.
The American College of Cardiology (ACC), the American Heart Association (AHA), and other expert organizations collaborated several years ago and released guidelines for the management of HF in 2013. These guidelines assisted clinicians when using many different drug options for HF patients, including ACE inhibitors, angiotensin II receptor blockers (ARBs), β-blockers, aldosterone antagonists, the combination of isosorbide dinitrate and hydralazine, digoxin and diuretics.
An Important Update
“Since 2013, there have been significant advances in the treatment of HF, including the introduction of effective new therapies that can potentially impact a large number of patients,” says Michael M. Givertz, MD. In 2016, the ACC and AHA teamed up with HFSA to update this work by publishing a focused update on new pharmacological therapy for HF. “This collaboration is unique in that it represents a consensus from all three organizations on new therapies approved for HF that can have an important impact on long-term outcomes.”
Published jointly in the Journal of the American College of Cardiology, Circulation, and the Journal of Cardiac Failure, the guideline update provides information on two new HF medications: valsartan/sacubitril, an angiotensin receptor-neprilysin inhibitor (ARNI), and ivabradine, a sinoatrial node modulator. Data have demonstrated that these agents are effective treatment options for some stage C HF patients who have a reduced ejection fraction.
The update notes that—when applied judiciously—valsartan/sacubitril and ivabradine can complement established pharmacological and device-based therapies. These therapies represent a milestone in the evolution of care for patients with HF, says Dr. Givertz, who was a member of the writing group that developed the update. “Treatment options for these patients have expanded considerably and there is now more hope than ever before to enhance patient outcomes.”
Consider Risks & Benefits
The update offers guidance on the appropriate use of valsartan/sacubitril and ivabradine in an effort to minimize confusion and improve the care of patients with HF. “Not every patient with HF will be a good candidate for these drugs, but the guidelines can help physicians decide the best candidates for these treatments,” says Dr. Givertz. “The document details the benefits and risks of these new therapies and offers insights as to when patients may need to be directed towards alternative therapies.”
According to the guideline update, a therapeutic regimen consisting of an ACE inhibitor or ARB or ARNI along with a β-blocker and an aldosterone antagonist is the new recommended therapy for patients with chronic symptomatic HF with reduced ejection fraction (Table). ARNIs should replace ACE inhibitors (or ARBs) in stable patients with mild-to-moderate HF who have adequate blood pressure levels and are otherwise tolerating standard therapies well. The guidelines note, however, that ARNIs should not be used with an ACE inhibitor or by patients with a history of angioedema. In addition, blood pressure should be monitored closely during up-titration.
The update also notes that ivabradine may be beneficial in reducing HF hospitalization rates among patients with symptomatic stable chronic HF with reduced ejection fraction who are receiving guideline-directed evaluation and management, including a β-blocker at a maximum tolerated dose. Specifically, ivabradine should be targeted to patients who are in sinus rhythm, with a heart rate of 70 beats per minute or greater, at rest. Given the well-proven mortality benefits of β-blocker therapy, the guidelines note it is important to initiate and up-titrate these agents to target doses, as tolerated, before assessing the resting heart rate for consideration of initiating ivabradine.
More to Come
According to Dr. Givertz, more data is still expected on how to optimize treatment for patients with stage C HF. “These guidelines are the first of a series of updates that will be coming out soon,” he says. “They serve as a ‘living document’ for clinicians managing patients with HF. We also anticipate future updates as more data describe how to further improve patient outcomes, especially with regard to prevention.”
The guideline notes that no single clinical trial answers all pertinent questions, nor can trial results be perfectly replicated in clinical practice. “Several critical questions remain unanswered, and further experience in both ongoing trials and clinical therapeutics may require modification of these recommendations,” says Dr. Givertz. “However, based on the currently available evidence, these recommendations reflect how we feel it is best to proceed with these medications today.”
Yancy CW, Jessup M, Bozkurt B, et al. 2016 ACC/AHA/HFSA focused update on new pharmacological therapy for heart failure: an update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. Circulation. 2016 May 20 [Epub ahead of print]. Available at: http://circ.ahajournals.org/content/early/2016/05/18/CIR.0000000000000435.
Arnett DK, Goodman RA, Halperin JL, et al. AHA/ACC/HHS strategies to enhance application of clinical practice guidelines in patients with cardiovascular disease and comorbid conditions: from the American Heart Association, American College of Cardiology, and U.S. Department of Health and Human Services. Circulation. 2014;130:1662-1667.
Halperin JL, Levine GN, Al-Khatib SM, et al. Further evolution of the ACC/AHA clinical practice guideline recommendation classification system: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2016;133:1426-1428.